Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

This study has been completed.
Sponsor:
Information provided by:
3M
ClinicalTrials.gov Identifier:
NCT00406549
First received: November 30, 2006
Last updated: March 7, 2007
Last verified: March 2007
  Purpose

To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.


Condition
Staphylococcus Aureus

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods

Resource links provided by NLM:


Further study details as provided by 3M:

Estimated Enrollment: 2000
Study Start Date: December 2006
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects 18 years of age or older, male or female and from any race or culture.
  2. Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.

Exclusion Criteria:

  1. Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
  2. Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406549

Locations
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85017
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Atlanta Institute for Medical Research
Decatur, Georgia, United States, 30030
United States, Illinois
Northwestern Univesity
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
France
Hospital Bichat
Paris, France, 75877
Germany
University of Muenster Hospital and Clinics
Muenster, Germany, 48149
Netherlands
Amphia Hospital
Breda, Netherlands, 4818CK
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Steve Gordon, M.D. The Cleveland Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00406549     History of Changes
Other Study ID Numbers: I2MS 05-010077
Study First Received: November 30, 2006
Last Updated: March 7, 2007
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 3M:
Staphylococcus aureus
Nasal colonization
pre-surgical patients
Sensitivity
Specificity
Nasal Staphylococcus aureus in pre-surgical patients

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 23, 2014